Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy

NCT06325501 | Recruiting Phase 3 DMC

• 1 other identifier: AA-2024-1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion. Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps. Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia. Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.

Conditions

Myoma;Uterus

Keywords

misoprostol; oxytocin; myomectomy; blood loss

Outcome Measures

Primary Outcomes (1)

• intra-operative blood loss

  which was measured at the end of surgery by calculating the sum of blood in the suction bottle and the blood absorbed in the sponges. Dry sponges were weighed before the surgery and the blood-soaked sponges were weighed at the end of the surgery

  time of surgery

Secondary Outcomes (3)

• blood transfusion

  24 hours

• post-operative Hb

  24 hours

• total surgery time

  24 hours

Study Arms (2)

misoprostol

ACTIVE COMPARATOR

receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery

Drug: Misoprostol 200mcg Tab

oxytocin

ACTIVE COMPARATOR

After the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour

Drug: Oxytocin

Interventions

Misoprostol 200mcg Tab DRUG

receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery

Also known as: Misotac

misoprostol

Oxytocin DRUG

after the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour

Also known as: syntocinone

oxytocin

Eligibility Criteria

• Age: 20 Years - 48 Years
• Gender Eligibility Details: 20-48 years old with symptomatic uterine myoma indicating operative management, abnormal uterine bleeding or bulk-related symptoms, females with infertility or recurrent pregnancy loss, pressure symptoms, and large myoma(s).
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• History of previous myomectomy
• Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
• Hypertension.
• Cardiac and Pulmonary diseases.
• Patients who have bleeding disorders.
• Patients on antiplatelets or anticoagulant before surgery.
• Anemia (Hb \< 10g %).
• Chronic endocrine or metabolic diseases such as Diabetes.
• Renal and hepatic impairment.
• Moderate and morbid Obesity (body mass index \> 35 kg/m2).
• Cases that will require intraoperative conversion of myomectomy to hysterectomy.
• Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8.
• history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine, Kasr el ainy hospital, Cairo university

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Myofibroma; Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tarek N Anees, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

waleed M El-khayat, MD

CONTACT

01005263580; waleed_elkhyat@yahoo.com

mona s Moghazy, MD

CONTACT

+447492650184; Moghazymona@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)